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Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute cough has a 3~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.The drug in this study is for post-infection cough in subacute cough. After long-term clinical practice, six traditional Chinese medicines, including Aster, Lonicera japonica, Shegan, dried ginger, mango seed and Schizonepeta tenuifolia, were selected to form Zihua Wenfei Zhisou Decoction. This product has the effect of relieving wind, relieving cough, warming the lung and resolving phlegm. It can be used for the cough syndrome caused by Wind-cold invading lungs syndrome. The aim is to evaluate the efficacy and safety of Zihua Wenfei Zhisou Granule in the treatment of postinfection cough (wind-cold lung syndrome) with placebo as a control.
Patients in treatment arm were given Zihua Wenfei Zhisou Granule (15 g/bag, one bag at a time, three times/day). Patients in placebo treatment arm were given Zihua Wenfei Zhisou Granule-matched placebo (15 g/bag, one bag at a time, three times/day). All treatment lasted for 14 days and no other antitussive/decongestant or bronchodilators are given to any patients. After that, there will be a follow-up 14 days after drug withdrawal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zihua Wenfei Zhisou Granule | Experimental | Patients in experimental treatment arm were given Zihua Wenfei Zhisou Granule (15 g/bag, one bag at a time, three times/day ). All treatment lasted for 14 days and no other antitussive/decongestant or bronchodilators are given to any patients. |
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| Zihua Wenfei Zhisou Granule-matched placebo | Placebo Comparator | Patients in placebo treatment arm were given Zihua Wenfei Zhisou Granule-matched placebo (15 g/bag, one bag at a time, three times/day ). All treatment lasted for 14 days and no other antitussive/decongestant or bronchodilators are given to any patients. Placebo does not contain active pharmaceutical ingredients, and its main ingredients are lactose, beta-cyclodextrin, stevioside, and caramel. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zihua Wenfei Zhisou Granule | Drug | 14 daily- doses of Zihua Wenfei Zhisou Granule,one bag at a time (15 g/bag), three times/day |
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| Measure | Description | Time Frame |
|---|---|---|
| Cough relief rate | Cough relief refers to a 50% or more reduction in cough VAS score | day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate of cough | Complete remission of cough refers to cough VAS score<17 mm | day 14 |
| Time to cough relief | Time to cough relief |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Mao | Contact | 18980601724 | maobing@medmail.com.cn | |
| Hongli Jiang | Contact | 18980606651 | doc_jhl@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Placebo | Drug | 14 daily- doses of placebo,one bag at a time (15 g/bag), three times/day |
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| day 14 |
| Complete remission time of cough | Complete remission time of cough | day 14 |
| Change from baseline in Cough Evaluation Test (CET) value | Change from baseline in Cough Evaluation Test (CET) value | day 0、day 7、day 14 |
| Change from baseline in visual analogue scale (VAS) value | The visual analogue scale (VAS) is a 100 mm scale, with a minimum value of 0 mm and a maximum value of 100 mm. 0 mm means that the cough is not troubled at all, and 100 mm means that the cough is the most troubled. | day 0、day 7、day 14 |
| Change from baseline in TCM syndrome score | Change from baseline in TCM syndrome score | day 0、day 7、day 14 |
| Change from baseline in Leicester Cough Questionnaire (LCQ) score | The LCQ comprises 19 items and takes 5 to 10 minutes to complete. The LCQ is a validated QoL measurement tool for non-specific cough and assesses the impact of cough on various aspects of life, including emotions, sleeping behaviour, work and relationships. It contains 19 items which are divided over 3 domains: physical (8 items), psychological (7 items) and social (4 items), with a 7-point Likert response scale. | day 0、day 14、day 28 |
| D013568 | Pathological Conditions, Signs and Symptoms |